Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis

NCT ID: NCT03658668

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2021-06-10

Brief Summary

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).

Portions of this study may be completed remotely.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active tDCS+PA

Group Type: EXPERIMENTAL

active tDCS

Intervention Type: DEVICE

tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability.

Physical Activity (PA)

Intervention Type: OTHER

20 minutes of cycling on an ergonomic cross-trainer

sham tDCS+PA

Group Type: SHAM_COMPARATOR

sham tDCS

Intervention Type: DEVICE

During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.

Physical Activity (PA)

Intervention Type: OTHER

20 minutes of cycling on an ergonomic cross-trainer

Interventions

active tDCS

tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\<4 mA) to induce changes in cortical excitability.

Intervention Type: DEVICE

sham tDCS

During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.

Intervention Type: DEVICE

Physical Activity (PA)

20 minutes of cycling on an ergonomic cross-trainer

Intervention Type: OTHER

Other Intervention Names

Soterix 1x1 tDCS mini-CT

Eligibility Criteria

Inclusion Criteria

• Stable and continuous access to internet service at home
• Adequate home facilities (enough space, access to quiet and distraction free area)
• Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
• Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
• Clinically stable and stable on treatment with disease modifying agents at least from 6 months
• Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
• Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
• Able to use study equipment
• Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
• Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria

• Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
• Primary psychiatric disorder that would influence ability to participate
• Receiving current treatment for epilepsy
• Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
• History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
• Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
• Treatment for a communicable skin disorder currently or over the past 12 months
• History of uncontrolled or labile hypertension
• Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
• Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score < 85
• History of clinically significant abnormalities on electrocardiogram (EKG)
• Presence of chronic medical illness and/or severe ataxia
• Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
• Alcohol or other substance use disorder
• Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

References

Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.

Reference Type: DERIVED

PMID: 32431658 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-00534

Identifier Type: -

Identifier Source: org_study_id